Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 1:19 AM
NCT ID:
NCT03977493
Eligibility Criteria:
Inclusion Criteria:
* Informed Consent as documented by signature
* Age ≥ 18 years
* Focal hand dystonia (FHD). Diagnosis must be made by a neurologist specialized in movement disorder (at least 2 years specific training, all partners listed have at least 2 years training)
* Both idiopathic and secondary FHD are allowed
* Both drug naive subjects and subjects previously treated with other BoNT-A will be included
* Patients must be willing and able to comply with the study procedures
* Female patients of childbearing potential must agree to use an effective method of contraception during the treatment period
Exclusion Criteria:
* Presence of spasticity, or other central sensorimotor lesion of motor system other than dystonia in the affected limb
* Peripheral nerve lesion (diagnosis either clinical or electrophysiological) in the affected limb, for example with a muscle weakness at baseline
* Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to BoNT-A toxins including IncobotulinumtoxinA
* Doses and schedules of any ongoing treatment with potential confounding drugs such as muscle relaxants (for example Tolperison, Tizinadid, Baclofen, Mestinon, Dantrolen), benzodiazepine, neuroleptics or antidepressants have to be kept unchanged throughout the study and no changes should be made between the first trial injection and the end of study visit at week 12.
* Previous treatment with other BoNT-A less than 3 months before the inclusion in this study
* Women who are pregnant or breast feeding,
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
* Participation in another study with investigational drug within the 30 days preceding and during the present study
* Previous enrolment into the current study
* Enrolment of the investigator, his/her family members, employees and other dependent persons
* Severe depression (\>29 as measured with the Beck Depression Inventory, see Appendix 8) or other relevant psychiatric disorder
* INR \> 2 on the day of injection if the patient is anticoagulated. If INR \> 2, the study injection will be delayed until the return to a safer INR.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03977493
Study Brief:
Protocol Section:
NCT03977493